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Group Effect in Full Replicate Design [RSABE / ABEL]

posted by Helmut Homepage - Vienna, Austria, 2018-09-12 15:31  - Posting: # 19278
Views: 267

Hi GM,

» » For the ABE part (if swR <0.294) like the FDA’s Model II:
  • fixed:
    » » Group, Sequence, Treatment, Period (nested within Group), Group-by-Sequence Interaction
    » »
  • random:
    » » Subject (nested within Group × Sequence)

»
» But as per Progesterone Guidance, Treatment as random term in Average BE.

No way.

» Please see model SAS code from guidance.
»
» MODEL LAUCT = SEQ PER TRT/ DDFM=SATTERTH;
» RANDOM TRT/TYPE=FA0(2) SUB=SUBJ G;

Please make yourself familiar with the syntax of SAS’ PROC MIXED. Terms in the MODEL argument are fixed.

» As per your version, Subject (nested within Group × Sequence) is the random term.
»
» Now am Confused:ponder:,Which is the correct one?

Mine. For the exact setup ask a qualified SAS-coder.

Cheers,
Helmut Schütz
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